A Phase 1 interventional study of EPI-003 in Chronic Hepatitis B and HBV (Hepatitis B Virus), sponsored by Epigenic Therapeutics, Inc. Not yet recruiting at 4 sites in 3 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-10-28.
Sponsored by Epigenic Therapeutics, Inc · Phase 1, Interventional, and Treatment
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Among 82 studies in Hepatitis B, Chronic with a site in New Zealand — 8 open to participants now, 10 under way, none of them phase 3. Hepatitis B, Chronic · New Zealand.
Among the 82 studies in Hepatitis B, Chronic with a site in New Zealand, this one is the 60th largest by planned enrollment of the 76 interventional ones that give a count, is one of 6 that started in 2024, is one of 38 in phase 1, and was the 74th registered.
895 studies on the registry are indexed under Hepatitis B, Chronic; 152 are open to participants now.
Browse Hepatitis B, Chronic studies →8 of the 82 studies in Hepatitis B, Chronic with a site in New Zealand are open now. Recruiting first, the newest first:
AusperBio Therapeutics Inc. · Sites in New Zealand, Australia, China and 4 more countries
Ages 18–65
IntegerBio · Sites in New Zealand, Hong Kong, Moldova and 1 more country
Ages 18–70 · Healthy volunteers
nChroma Bio · Sites in New Zealand, France, Hong Kong and 1 more country
Ages 18–64
Tune Therapeutics, Inc. · Sites in New Zealand, Hong Kong, Moldova
Ages 18–75
Precision BioSciences, Inc. · Sites in New Zealand, United States, France and 3 more countries
Ages 18–70
A study can be open while its sites in New Zealand have not opened yet or have stopped. Only those recruiting at a site in New Zealand →
Of the 97 Hepatitis B, Chronic studies recruiting now, 33 (34%) set no upper age limit and 59 (61%) stop at 75 or younger; 11 take children under 18; 13 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
82 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 40 · Phase 2 27 · Phase 3 9 · Phase 4 3
First in 2002; this study’s year is marked. 6 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 36 is below the median of 100 across 659 interventional studies indexed under Hepatitis B, Chronic.
Median enrollment 84 across the 76 interventional studies, 300 across the 6 observational. Of the 71 that completed or were terminated, 36 (51%) have results posted.
This tab as a report to print or save as PDF → With an account.
82 of 82 have an industry lead sponsor. The 10 most frequent:
Epigenic Therapeutics, Inc is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Epigenic Therapeutics, Inc has 2 studies filed under Hepatitis B, Chronic — fewer than ten, so there is no comparison to draw.
6 of the studies in Hepatitis B, Chronic with a site in New Zealand that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06680232Precision BioSciences, Inc.Phase 1 Study to Evaluate Safety and Antiviral Activity of PBGENE-HBV in Adult Patients With Chronic Hepatitis B | 2026-12 |
| NCT06963710Aligos TherapeuticsA Study Evaluating the Efficacy and Safety of ALG-000184 Compared With Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg- Negative Adult Subjects With Chronic Hepatitis B (B-SUPREME) | 2027-03 |
| NCT07389044IntegerBioA Study on IB-001 Dose Response and Tolerability in Healthy Adults and Those With Chronic Hepatitis B | 2027-04-30 |
| NCT06537414GlaxoSmithKlineA Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB) | 2027-05-31 |
| NCT06661148Epigenic Therapeutics, IncStudy of EPI-003 in Select Nucleos(t)Ide Analogue-Treated, Chronic Hepatitis B Patients | 2027-06-30 |
Add all 6 to your calendar (.ics) → With an account.
Among the 82 studies in Hepatitis B, Chronic with a site in New Zealand, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study is an open-label, 2-Part (Single Ascending Dose [Part 1] And Dose Expansion) study that will evaluate the safety of EPI-003 administered to patients with chronic infection with HBV (CHB). EPI-003 is a liver-targeted antiviral therapeutic for intravenous (IV) injection that is capable of precise epigenetic modifications of the HBV genome without causing mutations in the gene sequence itself. This study is designed to determine the safety and pharmacokinetic (PK) and pharmacodynamic (PD) profile of EPI-003 in this patient population.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Part A：Single Ascending Dose； Part B：Dose Expansion
Drug: EPI-003
Intravenous (IV) infusion.
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Time frame: From Baseline through to Day 28 postdose
Change from baseline at different follow-up time points for HBsAg, HBsAb, HBV DNA, HBV pgRNA and HBcrAg
Change from baseline at different follow-up time points for HBsAg, HBsAb, HBV DNA, HBV pgRNA and HBcrAg
Time frame: From Baseline (predose on Day 1) at Day 3, Day 7, Day 14, Day 28, Day 56, Day 84, Day 112, and Day 182, and Day 365 postdose for the following parameters
Evaluation of maximum observed concentration (Cmax)
Evaluation of maximum observed concentration (Cmax)
Time frame: Day 1, Day 3, Day 14, and Day 28
Evaluation of maximum observed concentration (tmax)
Evaluation of maximum observed concentration (tmax)
Time frame: Day 1, Day 3, Day 14, and Day 28
Evaluation of terminal elimination half-life (t1/2)
Evaluation of terminal elimination half-life (t1/2)
Time frame: Day 1, Day 3, Day 14, and Day 28
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Time frame: Up to day365
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2024; primary completion for Jun 2027, 30 months later.
Of 73 industry-sponsored phase 1 interventional studies under Hepatitis B, Chronic, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 30 months is above that.
Counting every sponsor, half of 81 studies reached it within 16 months; a quarter within 6 and three quarters within 27.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Epigenic Therapeutics, Inc